The purpose of this Support Center is to provide technical support, resources, tips, and answers to frequently asked questions regarding the CITI Program. We welcome contributions and feedback so please contact us with anything regarding the CITI Program or this Support Center.

Final Revisions to the Common Rule

On 19 January 2017, the U.S. Department of Health and Human Services (HHS) issued a final rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of human Subjects" (the Common Rule).  The revisions are intended to reflect changes in the types of human subjects research being conducted and the landscape of research since the original rule published in 1974 and last revised by 15 U.S. federal department agencies in 1991.  The changes also aim to reduce the administrative and regulatory burden of the current rule (known as the pre-2018 rule), as well as better protect human subjects in research.


What are the changes?

The HHS press release encompasses the most significant changes adopted in the final rule.  The federal register includes an executive summary outlining the changes as well as the final regulatory text.

Final rule changes include:
  • Improving the informed consent document and process to increase subject understanding
  • Requiring that consent forms for certain federally funded clinical trials be posted on a public website
  • Requiring single Institutional Review Board (sIRB) review for cooperative research for some studies
  • Allowing the use of broad consent for future research for secondary studies on stored identifiable data or identifiable biospecimens
  • Eliminating continuing review for certain minimal risk research
  • Establishing new exempt categories of research based on level of risk posed to subjects
  • Adopting the definition of “Clinical Trial” that includes behavioral health-related outcomes
Because the final rule changes affect many areas of research (including biomedical and social behavioral), institutional officials and staff, IRB administrators and members, researchers, and sponsors all need to understand and prepare to implement the changes.

The effective date is on 19 January 2018 for all changes except cooperative research (45 CFR 46.114). Changes to cooperative research requirements will be effective on 20 January 2020.  

CITI Program's Plan


CITI Program will be addressing the changes in several ways including updating content to reflect the new requirements. As always, we will keep organizations abreast of our actions through email and web announcements.

Our colleague Gary Chadwick, Senior Consultant at HRP Consulting Group, has summarized the changes which can be found on the HRP Consulting Group Website  “New Final Common Rule - Summary of Changes.”  


Resources


 

Last Updated: Apr 19, 2017 02:18PM EDT

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